Effect of Donepezil on Smoking

Completed · Phase 2 · Has a placebo group

Conditions studied: Smoking

In brief

The objective of this proof-of-concept pilot study is to evaluate Donepezil HCL (Aricept) for side effects and effects on smoking behavior and performance on neurocognitive tasks in a population of dependent smokers.

Key facts

Study ID

NCT01250977

Run by

Abramson Cancer Center at Penn Medicine

People needed

30

Starts

2011-01-11

Expected to finish

2011-12-06

Last updated by the study team

2019-07-11

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 30 smokers ages 18-50 who have smoked at least 10 cigarettes per day for the past 6 months, will be eligible to participate. They must be able to provide informed consent.

You may not qualify if…

• Smoking Behavior:
• Current enrollment or plans to enroll in a smoking cessation program, or use other smoking cessation medications in the next 2 months.
• Provide a CO reading less than 10 ppm at medical screening.
• Participants who roll their own cigarettes.
• Regular use of chewing tobacco or snus.
• Alcohol/Drugs 1) History of substance abuse and/or currently receiving treatment for substance abuse (e.g. alcohol, opioids, cocaine, marijuana, or stimulants). 2) Current alcohol consumption that exceeds 25 standard drinks/week. 3) Providing a breath alcohol concentration (BrAC) reading of greater than or equal to 0.01 at medical screen, baseline, or testing sessions.
• Medical:
• Women who are pregnant, planning a pregnancy, or lactating; all female subjects shall undergo a urine pregnancy test prior to enrollment and must agree in writing to use an approved method of contraception.
• Lifetime history or current diagnosis of psychosis, bipolar disorder, anxiety disorder, or schizophrenia, as identified by the MINI. Individuals with a past history of depression are eligible as long as their major depression episode was more than 6 months ago.
• Serious or unstable disease within the past 6 months i.e. heart disease, liver/kidney failure)
• Other medical conditions such as peptic ulcer disease; beign prostatic hypertrophy or bladder outflow problems; asthma or chronic obstructive pulmonary disease.
• BP reading of 170/100 at medical screening session.
• Medication:
• Current use, recent discontinuation within last 14 days or planned use of the following medications:
• Any form of smoking cessation medication, i.e. Zyban, Wellbutrin, Wellbutrin SR, Chantix, nicotine replacement therapy
• Psychotropic medications (anti-psychotics, anti-depressants, anti-anxiety or anti-panic medications, mood stabilizers and stimulants)
• Current treatment with other acetylcholinesterase inhibitors (ACIs) like donepezil HCL (Aricept), tacrine, rivgastigmine and galantamine
• Anti-seizure meds, and other meds that affect the cholinergic system such as mecamylamine, atropine, succinylcholine, ketocaonazole, quinidine, bethanechol, iprapropium, bromide, dicyclomine, benztropine, carisprodol, zantac, and procardia.
• Patients shallbe instructed to refrain from using any study prohibited drugs (note participants are allowed to take prescription medicines not in the exclusion list)throughout their participation in the study.
• Other
• Inability to complete the baseline study procedures within thee hours and/or correctly, as determined by the PI.
• Non-English speakers.

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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